Measures for the Examination and Approval of the Bio-Safety Administration of Highly Pathogenic Animal Pathogenic Microbe Labs

Order of the Ministry of Agriculture [2005] No. 52

The Measures for the Examination and Approval of the Bio-safety Administration of Highly Pathogenic Animal Pathogenic Microbe Labs, which were adopted at the 10th executive meeting of the Ministry of Agriculture upon deliberation, are hereby promulgated and shall come into force as of the date of Promulgation.

Minister Du Qinglin
May 20, 2005

Measures for the Examination and Approval of the Bio-Safety Administration of Highly Pathogenic Animal Pathogenic Microbe Labs

Chapter I General Provisions

Article 1 The present Measures are formulated according to the Regulation on the Bio-safety Management of Pathogenic Microbe Labs in order to regulate the examination and approval for the bio-safety administration of highly pathogenic animal pathogenic microbe labs.

Article 2 The examination and approval of qualification and experimental activities of highly pathogenic animal pathogenic microbe labs and transportation of highly pathogenic animal pathogenic microbe shall be governed by the present Measures.

Article 3 The term "highly pathogenic animal pathogenic microbes" as mentioned in the present Measures refers to the microbes in categories I and II as prescribed in the Classified Catalog of Animal Pathogenic Microbes that root in animals.
The Classified Catalog of Animal Pathogenic Microbes shall be formulated, amended and promulgated by the Ministry of Agriculture in collaboration with the relevant departments of the State Council.

Article 4 The Ministry of Agriculture shall take charge of the bio-safety administration of highly pathogenic animal pathogenic microbe labs in the whole country.
The administrative departments of veterinary of the people's government at or above the county level shall take charge of the bio-safety administration of highly pathogenic animal pathogenic microbe labs within the administrative divisions thereof.

Chapter II Examination and Approval of Lab Qualification

Article 5 Where a lab engages in any experimental activity concerning highly pathogenic animal pathogenic microbes, it shall obtain the Qualification Certificate of Highly Pathogenic Animal Pathogenic Microbe Labs as issued by the Ministry of Agriculture.

Article 6 Where a lab applies for the Qualification Certificate of Highly Pathogenic Animal Pathogenic Microbe Labs, it shall meet the following requirements:
1. It engages in such activities as researches, testing, diagnosis, and storage of bacterium (virus) strains concerning any animal epidemic disease according to law;
2. It meets the requirements of the Regulation on the Safety Administration of Veterinary Labs as promulgated by the Ministry of Agriculture;
3. It has obtained the national accreditation certificates of safe bio-labs of Grade III or IV;
4. The personnel thereof that engage in experimental activities shall have academic background at or above junior college or professional titles above mid-grade in relevant majors related to veterinary and have received bio-safety trainings; and
5. The engineering quality of the lab has passed inspection and acceptance according to law.

Article 7 An applicant that meets the requirements as prescribed in the preceding Article may file an application to the local administrative department of veterinary of the people's government of the province, autonomous region or municipality directly under the Central Government and submit the following materials:
1. The Qualification Application Form for Highly Pathogenic Animal Pathogenic Microbe Labs in duplicate;
2. Management brochure of the lab;
3. A photocopy of the accreditation certificate of a national lab;
4. A photocopy of the legal-person qualification certificate of the entity that establishes the lab;
5.
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